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Efficacy and safety of allogeneic bone marrow transplantation for severe type II aplastic anemia

The efficacy and safety of allogeneic bone marrow transplantation in the treatment of severe type II aplastic anemia: a multicenter, single arm, prospective study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016524
Enrollment
Unknown
Registered
2018-06-06
Start date
2018-06-12
Completion date
Unknown
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe type II aplastic anemia

Interventions

Case series:allogeneic bone marrow transplantation

Sponsors

Department of Hematology, Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) must be able to understand the test plan, comply with the doctor's advice, and sign informed consent; 2) Aged 2 to 60 years old. 3) according to the diagnostic criteria of severe aplastic anemia type II: the patients with chronic aplastic anemia had two of the following three items: the absolute value of reticulocyte 5/10) haplotype donors, donor aged 8-65 years old, no contraindication of donor (except for hematological diseases, malignant tumors, infectious diseases, severe organ dysfunction, mental illness, etc.); 12) no active infection; 13) the pregnancy test for women of childbearing age must be negative, and agreed to use effective contraception during treatment and subsequent one year.

Exclusion criteria

Exclusion criteria: 1) exclude paroxysmal nocturnal hemoglobinuria, myelodysplastic syndrome and congenital genetic diseases; 2) combined with serious heart and lung liver and kidney disease; 3) specific allergic constitution and intolerance to medication; 4) active HBV hepatitis, HCV antibody positive; 5) serious disease which may be restrictions of the patient's participation (e.g., progressive infection and / or active infection, drug-resistant bacterial infection, septicemia, non controlled diabetes, severe cardiac insufficiency or angina, and liver and kidney insufficiency); 6) participating in other clinical trials or participating in other drug clinical trials within 3 months; 7) women who laced or did not take effective contraception or pregnancy; 8) the mental state is unstable; 9) the researchers believe that patients who are not suitable for this treatment.

Design outcomes

Primary

MeasureTime frame
EFS of 1 year;30 day implantation rate;100 day implantation rate;

Secondary

MeasureTime frame
1 year OS;TRM;

Countries

China

Contacts

Public ContactYan Jinsong

Second Affiliated Hospital of Dalian Medical University

yanjsdmu@126.com+86 13909863628

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026